Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

NCT01244763 | Completed Phase 2 Results DMC

• 1 other identifier: FGCL-4592-041
• Study Type: interventional
• Target: 145
• Locations: 2 countries
• Sites: 38

Brief Summary

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.

Conditions

Chronic Kidney Disease; Anemia

Keywords

Kidney; Chronic Kidney Disease; CKD; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Erythropoietin; Blood count; Predialysis; Pre-dialysis; Hb; Non-dialysis

Outcome Measures

Primary Outcomes (1)

• Number (%) of Participants With an Hb Response by Week 17

  An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

  Up to Week 17

Secondary Outcomes (19)

• Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25

  Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

• Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25

  Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

• Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

  Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

• Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28

  Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

• Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25

  Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

Study Arms (6)

Cohort A: Roxadustat Tiered, Weight Based Dosing TIW

EXPERIMENTAL

Participants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kilograms (kg)\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.

Drug: Roxadustat

Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW

EXPERIMENTAL

Participants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.

Drug: Roxadustat

Cohort C: Roxadustat at 50 mg TIW

EXPERIMENTAL

Participants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.

Drug: Roxadustat

Cohort D: Roxadustat at 100 mg TIW

EXPERIMENTAL

Participants will receive roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.

Drug: Roxadustat

Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QW

EXPERIMENTAL

Participants will receive roxadustat capsules for 24 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 70, 100, and 150 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.

Drug: Roxadustat

Cohort F: Roxadustat at 70 mg BIW then QW

EXPERIMENTAL

Participants will receive roxadustat capsules at 70 mg for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency will be reduced from BIW to QW.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Oral capsule

Also known as: FG-4592

Cohort A: Roxadustat Tiered, Weight Based Dosing TIW; Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW; Cohort C: Roxadustat at 50 mg TIW; Cohort D: Roxadustat at 100 mg TIW; Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QW; Cohort F: Roxadustat at 70 mg BIW then QW

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years
• Chronic kidney disease, not receiving dialysis
• Body weight 45 to 140 kg

You may not qualify if:

• Any clinically significant infection or evidence of an underlying infection
• Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
• History of chronic liver disease
• New York Heart Association Class III or IV congestive heart failure
• Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
• History of malignancy
• Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
• History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
• History of hemosiderosis, hemochromatosis or polycystic kidney disease
• Active hemolysis or diagnosis of hemolytic syndrome
• Uncontrolled or symptomatic secondary hyperparathyroidism
• Seizure disorder or receiving anti-epilepsy medication
• Known bone marrow fibrosis
• Any prior or scheduled organ transplant
• Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor

Sponsors & Collaborators

• Kyntra Bio: lead
• Astellas Pharma Inc: collaborator

Study Sites (38)

Unknown Facility

Mobile, Alabama, United States

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Pine Bluff, Arkansas, United States

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Azusa, California, United States

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Chula Vista, California, United States

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Downey, California, United States

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Northridge, California, United States

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Paramount, California, United States

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Riverside, California, United States

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Whittier, California, United States

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Yuba City, California, United States

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Fort Lauderdale, Florida, United States

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Lauderdale Lakes, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Meridian, Idaho, United States

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Wichita, Kansas, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Bethesda, Maryland, United States

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Detroit, Michigan, United States

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Lincoln, Nebraska, United States

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Mount Laurel, New Jersey, United States

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Mineola, New York, United States

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New York, New York, United States

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Asheville, North Carolina, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Orangeburg, South Carolina, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Fairfax, Virginia, United States

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Caguas, Puerto Rico

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Ponce, Puerto Rico

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San Juan, Puerto Rico

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Related Publications (1)

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

  PMID: 36005278 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

415-978-1441

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 19, 2010
• Study Start: October 29, 2010
• Primary Completion: June 13, 2012
• Study Completion: June 13, 2012
• Last Updated: February 10, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-01

Locations

US (35); PR (3)